Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-Saline in Asthma - Full Text View

Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-Saline in Asthma (FluSAL)

This study has been completed.

First Received: January 21, 2008 No Changes Posted

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) GlaxoSmithKline
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00606242

Purpose

This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-Saline Induced Bronchoconstriction in Asthmatic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

FEV1 [ Time Frame: Measured every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PC20 methacholine [ Time Frame: Measured every 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	January 2000
Study Completion Date:	December 2007
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low dose steroid: Active Comparator Fluticasone, 100 mcg per day	Drug: Fluticasone Inhaled Fluticasone, either 100 or 1000 mcg per day
High dose steroid: Active Comparator Fluticasone, 1000 mcg per day	Drug: Fluticasone Inhaled Fluticasone, either 100 or 1000 mcg per day

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of asthma

Exclusion Criteria:

Habitual cigarette smoking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606242

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( John Fahy )
Study ID Numbers:	HL6788-15958-08
Study First Received:	January 21, 2008
Last Updated:	January 21, 2008
ClinicalTrials.gov Identifier:	NCT00606242 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 03, 2009